SSRI Failure in the Treatment of
Social Anxiety Disorder (Social Phobia)
August 2007
socialfear.com
Do SSRI's get more attention than they deserve in the treatment of Social Anxiety Disorder? Since 1999, the FDA has approved two SSRI's (Paxil, Zoloft) and one SNRI (Effexor XR) for the treatment of generalized SP. "SRI" (SSRI and SNRI) studies have consistently shown a patient response rate to SSRI over placebo of only 15-25% in the treatment of Social Anxiety Disorder (Social Phobia).
Social Phobia study results thru 2006:
Nardil (phenelzine): 50-75%
Klonopin (clonazepam): 50-75%
Paxil CR (paroxetine): 15-25%
Zoloft (sertraline): 15-25%
Effexor XR (venlafaxine): 15-25%
Neurontin (gabapentin): 20%
Note: Study rates above are all "reponse over placebo" from double blind studies. Of the above drugs, the first two are "off patent" (generic), and the last four are "on patent". Drug studies for off patent drugs in Social Anxiety Disorder came to a virtual standstill upon the introduction of SSRI's (more on this follows). This has to do with financial considerations and profit seeking driven by major drug companies.
Before I begin I do not want anyone to be discouraged that the above medications and the associated percentages are their only "options". In practice, polypharmacy (combining 2 or more medications) is probably the norm in most of those getting very good SP treatment. The above percentages are based on "monotherapy" (single drug treatment) only. Please see my main website for information on how almost anyone can find an effective SP treatment regimen.
SRI studies have led to the following medications being FDA approved for Social Anxiety Disorder, between 1999 - present. These are Paxil (paroxetine), Zoloft (sertraline), and Effexor XR (venlafaxine). The recent studies conducted which were used to obtain FDA approval were funded primarily by the companies who market the respective drugs.
If we take these SRI FDA studies at "face value" - about 80% of patients GET NO BENEFIT AT ALL, and 20% notice at least some mild benefit. In the real world, it truly is difficult to find anyone at all who reports long-term high efficacy using an SRI (taken alone) for primary SP. Indeed the vast majority of those who try SSRI's (standalone) for the treatment of Primary Social Anxiety Disorder remain quite discouraged and symptomatic.
Still, the SRI's CAN be useful, perhaps even for a majority, for those with primary generalized SP, for a couple of reasons. This is because most often there are, or will be, secondary disorders which emerge (or already were present) - when people continue to suffer with chronic social anxiety symptoms. Depression, dysthymia, alcoholism, etc, are commonly seen either accompanying or as evolving "side effects" of long term untreated primary social anxiety. In this sense, SRI monotherapy may be "better than nothing" even when it FAILS to help treat the SP symptoms themselves. Depressions and other mood disorders may be better held in check, thus helping to reduce complications of the untreated SP.
The above mentioned utility of SRI's (to treat conditions secondary to SP) are important, but they do not answer the question "what about treating the SP itself?". SP, all by itself, can have devatasting impacts on the quality of a person's social and occupational functioning.
And if SRI's aren't the answer, why do we see TV ads promoting them for social anxiety?
Researchers (and the BILLION DOLLAR DRUG COMPANIES who provide the demand for their work) are ironically perhaps the largest promoters of ongoing confusion in the treatment of Social Phobia. We still see many promoters of "SSRI's" and/or "CBT" as the "most effective" treatments for Social Phobia. Most research money is getting to researchers from SSRI companies, whose drugs are still on patent for years to come. "Special Interests" are invading USA drug research much the way they have been increasingly corrupting USA politics in recent decades. The good news is that SP IS treatable - and the bad news is that we cannot necessarily trust our Dr. will know how to diagnose or to treat us well, nor that the hype surrounding the latest new drug which is investing millions to gain billions in new revenue is the answer for our problem. Nor that the researcher who makes his living off the money provided to promote the new drug will help us assess it accurately.
The better treatments are not new, nor are they obscure, unknown, unstudied, or even unacknowledged. They have simply been "out-promoted" by the billions of dollars of SSRI money which came into the picture during the mid to late 1990's at the same time that "generic" drugs were being discovered which WERE indeed highly efficacious in the treatment of Social Phobia. These more effective, generic drugs are typically cited in articles promoting SSRI's as "dangerous", "old", "addictive", or as "notorious for causing side effects". All of these claims cannot be supported by the latest available data, and never are. They are essential ignored, or described as "reserved only for those patients who do not respond to 'more conventional' treatment". Presumably the "convential" treatment are the relatively ineffective, "new" drugs which are on patent and lucrative for USA's #1 richest industry (the drug industry) - and it's supporting cast of researchers and promoters.
Look carefully for efficacy results in these SSRI promotions. Does it state in the article the NET patient response rate in studies (reporting the placebo response in addition to the drug receiving response), and the corresponding NET rates found with "old" drugs? Naturally it won't. Does it warn of risk with the highly efficacious Nardil of "hypertensive crisis" - yet fail to show how safe Nardil actually has proven to be in recent decades? Will it claim "addictiveness" as a risk with some other more effective SP meds - yet fail to elaborate - because it is not only unsupportable but disprovable? Misinformation relating to SSRI efficacy in Social Anxiety Disorder distracts attention from the truth that SSRI's are only very mildly effective overall in the monotherapy of Social Phobia, and are far inferior in general to some alternatives.
Looking at patient study results of the older generic drugs Klonopin (clonazepam) and Nardil (phenelzine) in the treatment of generalized Social Anxiety Disorder, we see reported net response rates for each averaging around 50-75%, despite the use of sometimes relatively low maximum dose "caps" in many of the double-blind studies. SRI studies have in contrast usually allowed flexible dosing to high levels.
Klonopin (clonazepam) has shown net response rates typically ranging from 50-75% (often with a fairly low maximum allowed dose). Dramatic reponses were typical, and "complete remission" was not uncommon. These studies were funded independently, without drug company motivation for drug study bias to gain luctrative FDA approval.
Nardil (phenelzine) has shown similarly high rates of response. Like Klonopin, when studies began during the early 1990's, Nardil (phenelzine) was already an "off patent generic" without manufacturer financial incentive to bias study results to obtain FDA approval. Net response rates (in mostly dose capped studies) fall in the 50%-75% range. With flexible dosing, the net response rate with Nardil is likely to be close to 70-90%, since it is now well accepted that the required dose range is usually 60-90mg (sometimes up to 115mg) and some studies capped the dose at between 60-75 per day.
The original patenters of Nardil, and of Klonopin, have never sought FDA approval in the treatment of Social Phobia, since as off patent "generics" they have nothing to gain from the substantial monetary investment required in seeking FDA approval. Even if they DID fund the required studies, any increase in sales of generic drugs would only displace sales of more expensive (and less effective) "on patent" alternatives.
The nature of things in the USA is to promote the new, expensive drugs even when there is no evidence that they are safer or more effective (or may even be substantially less effective).
We have yet to see any Klonopin vs. SRI study, nor a Nardil vs. SRI study. And as long as these SRI's are on patent, it is very doubtful we ever will. Such studies would without question be harmful to the continuing (and currently medically sustained) notion that SRI's are the "treatment of choice" for Social Anxiety Disorder. They may be a good "first try" medication, but rarely end up being a useful standalone drug treatment in SP.
"The World's most neglected anxiety disorder" of the 1990's continues to be so in the 2000's. Only 10% of those with Social Phobia seek treatment, and the vast majority of them receive the "FDA approved" SSRI's as their initial (and often only) treatment options. Most of these patients eventually drop their SRI due to lack of efficacy. In cases where a patient DOES remain on the SRI, it is often because it is effectively treating some *other* psychiatric disorder well (such as mild depression or dysthymia), but not because it is helping their Social Anxiety Disorder to any significant degree.
Continued gross lack of psychiatrist experience and insight (this is a worldwide problem) in treating Social Anxiety Disorder usually means the patient eventually leaves the Dr, without good treatment, or stays with him with ongoing inadequate treatment, and persists with disillusionment, frustration, and ongoing hopelessness about his/her life and future. For those so afflicted with moderate to severe generalized Social Anxiety Disorder, this is a tragedy!
In the above case, a patient must not give up! Most of us with Social Phobia CAN and WILL see dramatic improvement with appropriate treatment. To ensure the good treatment they deserve, the patient must (I believe in most cases still in 2007) self-educate - and must find a Dr. experienced enough in the treatment of Social Anxiety Disorder so that they can receive the treatment they deserve.
It is highly recommended here that the (understandably so) skeptical reader of this page read books by Gorman and by Marshall shown below. They are easily purchased online at low price and easy to read and reference. Both authors have prominent status as leading experts in psychiatry in the United States. Gorman has worked in a variety of settings including substantial work with Leibowitz (who initiated studies with Nardil in the treatment of Social Phobia), and few psychiatrists are more promominetly respected. Marshall heads the Anxiety Clinic at the University of Madison, Wisconsin; and probably has as much experience and insight into treating patients with Social Anxiety Disorder as anyone in the USA. Both books are highly respected among the medical community.
Highly recommended:
Social Phobia: From Shyness to Stagefright John Marshall, 1995
Essential Guide to Psychiatric Drugs Jack Gorman, 1997, 3rd rev.
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